Sterilizing Grade and Prefilter

Instructor: Mark Trotter
Product ID: 704703
  • Duration: 90 Min
This training program will review the latest industry filtration technologies and standards with an overview of regulatory requirements. It will also discuss why and how to determine which filter, the media, and pore ratings that are appropriate for various filtration applications. The program is designed for experienced as well as those new to biopharmaceutical processes. The need-to-know current requirements for specifying sterilizing grade and prefilters in biopharm processes will also be discussed.
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Why Should You Attend:

The webinar will cover form and function of sterilizing and prefilters. The topics covered include: various mechanism of particle and microbial removal, pore size ratings, typical filtration applications and an overview of functionality and integrity testing.

This webinar will review current standards and regulatory issues regarding filtration and discuss industry trends and developments. A theoretical and practical review of bacterial retentive filter, Integrity Testing, with do and don’ts and troubleshooting.

Learning Objectives:

  • Be able to identify process applications for sterilizing and prefilter usage.
  • Understand the concepts of filtration mechanisms in liquid and gases.
  • Determine filtration media uses for various filtration applications.
  • To be able to specify and qualify filters for these applications.
  • Understand the functional and integrity testing methods.

Areas Covered in the Webinar:

  • Definition of sterilizing grade and prefilters and pore size ratings
  • Terminology and definition of key terms and filtration functions
  • Filtration removal mechanism; sieving, adsorption
  • Mechanisms of entrapment/ removal in liquids /gases
  • Types of filter media; membrane versus depth filters
  • Material of construction: how to choose the right media
  • Function and integrity testing review
  • Qualification and validation topics
  • Overview of current industry standards and regulatory requirements

Who Will Benefit:

  • Process Development Engineers and Scientists
  • Pilot-Plant Staff
  • Production Management and Operations
  • Validation, QA/QC and RA Personnel

Instructor Profile:

Mark Trotter, with over twenty years’ experience in the pharmaceutical and life science industries, has a broad range of work experience, from pharmacologic chemistry research project leader to marketing management in the laboratory and process equipment industries. This extensive background in the biopharmaceutical sciences is coupled with an in-depth regulatory knowledge that supports his expertise in these areas of process validation and qualification.

He has specialized training and work experiences in filter membrane technologies, including sterilizing, prefiltration, chromatography as well as single-use disposables technologies. Upstream fermentation to downstream applications, including separations, clarification and purifications processes technologies, are areas of subject matter expertise he brings to the training, technology transfer and consulting services. He completed his post-graduate studies at Long Island University, C.W. Post College, earning his MS in Medical Microbiology and continuing on for his MBA in Finance.

Mr. Trotter has published numerous technical articles, book chapters and has contributed expert editorial comment on these subjects. He is a member of PDA (Parenteral Drug Association), ASM (American Society of Microbiology) International Society for Pharmaceutical Engineering, (ISPE.), and the American Society of Quality, (ASQ), serving on ASTM E55 Biopharma Group and the USP Filtration Expert Panel.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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